Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
Phase 1
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Drug: DA-5221_01-R1 + DA-5221_01-R2
- Registration Number
- NCT06616883
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Healthy volunteers
- BMI between 18 and 30 kg/m2
- Body weight: Male≥50kg, Female≥45kg
- Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
Exclusion Criteria
- Subjects with clinically significant medical history
- Subjects with history of drug abuse or addicted
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental: Sequence B DA-5221_01 - Experimental: Sequence B DA-5221_01-R1 + DA-5221_01-R2 - Experimental: Sequence A DA-5221_01-R1 + DA-5221_01-R2 - Experimental: Sequence A DA-5221_01 -
- Primary Outcome Measures
Name Time Method AUCt pre-dose~72 hours post-dose area under the curve
Cmax pre-dose~72 hours post-do maximum plasma concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bumin Hospital
🇰🇷Seoul, South Korea, Korea, Republic of